CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

• Conditions: Arthritis; Breast Neoplasms; Arthralgia; Genetic Polymorphism
• Interventions: Drug: Aromatase Inhibitor(Femara or Arimidex)

• Registration Number: NCT00973505
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Last Update Submitted: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Posted: 2009-09-09
• Primary Completion: 2010-09
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. The patient must sign the informed consent.
2. The patient must sign the informed consent of genetic screening test.
3. The patient must be between 18 years old and 80 years old who can make a decision independently.
4. The patient must be post-menopause status.
5. The patient should be the stage 1,2 or 3 of the breast cancer.
6. The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor).

Exclusion Criteria

1. The patient is pre-menopause status.
2. The test result of serum FSH level is below 30mU/ml.
3. The test result of the hormone receptor(ER & PR) is negative or unknown.
4. Patient's breast cancer stage is 4 which has systemic metastatics.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CYP19	Aromatase Inhibitor(Femara or Arimidex)	CYP19 genetic polymorphism

Primary Outcome Measures

Name	Time	Method
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level	6, 12 months

Secondary Outcome Measures

Name	Time	Method
EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI	3,6,12 months

Trial Locations

Locations (1)

Korea University Anam Hopital; 🇰🇷 Seoul, Korea, Republic of